This disclosure relates generally to the field of medical devices. More specifically, the disclosure relates to a method and device using impedance for the detection of fluid (e.g., blood) bleeding such as pericardial effusion, retroperitoneal effusion, etc.
Radiofrequency ablation (RF ablation) or other invasive cardiac procedures which involve operation within the cardiac chambers, coronary arteries or the heart's venous anatomy have saved many lives. These procedures often involve percutaneous access into the cardiac chambers or epicardial arterial or venous vessels. Catheter, pacing lead, sheath, or other types of device manipulations frequently are performed as key parts of these procedures. Examples of this include balloon angioplasty or stent placement. Often, catheter access to the femoral artery is needed to enable access to the heart or elsewhere in the body.
A rare but potentially dangerous complication of these and similar procedures is inadvertent perforation of the blood vessel into which the catheter is inserted. For example, the initial needle penetration into the blood vessel may inadvertently penetrate the backside of the blood vessel, not just the front side into which an introducer sheath and catheter are to be inserted. It is not unusual in clinical procedures for the occurrence of perforation to be heralded by the onset of hemodynamic derangements such as a drop in blood pressure. In such cases the existence of the backside blood vessel perforation may not be recognized by the medical staff until a drop in blood pressure is detected. Of critical clinical significance is that early detection of such perforation may allow the operator to implement interventions (for example discontinuation of peri-operative anticoagulation) that would mitigate the untoward consequences of pericardial effusion.
Hematomas, caused by the accumulation of blood outside the blood vessel resulting from the backside perforation during catheter insertion, may cause pain, blood loss, shock, or even death. Its detection unfortunately is often not noticed right away and frequently only noted after hypotension or other symptoms are noted.